Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer

Phase 4

• Conditions: Radiation-induced Oral Mucositis
• Interventions: Drug: Levofloxacin Injection; Drug: Compound Kushen Injection（CKI）

• Registration Number: NCT04204382
• Lead Sponsor: Shanxi Zhendong Pharmacy Co., Ltd

Brief Summary

Oral mucositis (OM) is an acute side effect of radiotherapy for head and neck cancer (HNC). OM associated pain affects oral functions and nutrition of the patient that may result in discontinuity of treatment.The purpose of this clinical study is to evaluate the therapeutic effects of Compound Kushen Injection (CKI) on oral mucositis caused by radiotherapy of head and neck cancer.

Detailed Description

Patients with oral mucositis caused by radiotherapy for Head and Neck Cancer，will be enrolled in the trial, then seprated randomly in two group,the experimental group treated with Levofloxacin injection plus CKI; the contral group treated with Levofloxacin injection only. Clinical grade of radioactive oral mucositis，Oral pain score，Completion and duration of interruption of radiotherapy， Completion of chemotherapy during concurrent chemoradiotherapy，weight change，Food intake (liquid food, semi liquid food)，recovery time of oral mucositis will be compared before treatment, 3 days, 5 days and 7 days after treatment between the experimental group and the control group.

Study Timeline

• Study Start: 2019-12-12
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-25
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Patients are pathologically diagnosed as stage III or stage Ⅳ squamous cell carcinoma of head and neck cancer (including nasopharyngeal carcinoma)and are in accordance with the diagnostic criteria of radiotherapy induced mucositis/ stomatitis;
2. Patients have no prior history of radiotherapy, and grade III oropharyngeal mucositis occured after the first radiotherapy;
3. Patients have no stomatological diseases such as ulcer, edema and exudation in the oropharyngeal mucosa before radiotherapy;
4. Eastern Cooperative Oncology Group (ECOG) performance Score is 0 or 1;
5. The function of each organ is basically normal, including: hemoglobins ≥ 9g/dL, platelets ≥ 80×10^9/L, leukocytes ≥ 3×10^9/L, liver function within 3 times the upper normal limit, creatinine clearance ≥ 60mL/min;
6. Patients aged between 18 and 75 years;
7. Patients have a life expectancy of at least 6 months;
8. Patients have fully understood the study and signed the informed consent voluntarily prior to any related procedures of the study.

Exclusion Criteria

1. Patients who have received CoKS or systemic antibiotic treatment within 2 weeks before treatment;
2. Patients who have a history of head or neck surgery (except biopsy);
3. Female patients who are pregnant or breast feeding or female of pregnancy potential with a positive pregnancy test before treatment;
4. Patients with serious or uncontrolled organic diseases or infections, such as decompensate cardiac function failure, pulmonary function failure, liver function failure, renal function failure, causing unability to tolerate radiotherapy;
5. Patients who have radiotherapy contraindications;
6. Patients who are allergic to the study medications or quinolones;
7. Patients have serious psychological or psychiatric disorders, drug abuse or alcohol dependence in the past;
8. Patients are currently participating in another clinical study or have participated in another clinical trial in the past 30 days;
9. The investigator believes that it is not appropriate to participate in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	Levofloxacin Injection	1. CKI was injected intravenously for 7 days, once a day, 20ml each time； 2. Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time,
control group	Levofloxacin Injection	Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.
test group	Compound Kushen Injection（CKI）	1. CKI was injected intravenously for 7 days, once a day, 20ml each time； 2. Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time,

Primary Outcome Measures

Name	Time	Method
Clinical grade of radioactive oral mucositis	From baseline to day 7.	Treatment efficacy measured by Chinese guideline "Clinical diagnosis and treatment guidelines for tumor"; Significant: no leukoplakia or ulcer of the oral mucosa, mild hyperemia(grade Ⅰ), able to eat regular diet.; Effective: moderate hyperemia of the oral mucosa, mild leukoplakia or patchy ulcerations(grade Ⅱ)，semi fluid intake, but not interfering with radiotherapy.; Ineffective: severe hyperemia of the oral mucosa, flaked leukoplakia or ulcer (grade III or above), fluid intake，severe symptoms interfering with radiation therapy , intravascular nutrition or antibiotic treatment.; Total effective rate = (significant + effective) / total cases × 100%.

Secondary Outcome Measures

Name	Time	Method
Recovery time of oral mucositis	From baseline to day 7.	Recovery time，defined as the days needs for the clinical grade of oral mucositis to fall to grade II.
Oral pain score	From baseline to day 7.	Oral pain are evaluated with Visual Analogue Score (VAS): 0 equal no pain and 10 equal worst imaginable pain.
Completion of radiotherapy during concurrent radiotherapy	From baseline to day 7.	Compare the proportion of patients completing radiotherapy between the two groups.
Duration of interruption of radiotherapy	From baseline to day 7.	Compare the days of interruption period of radiotherapy between the two groups.
Completion of chemotherapy during concurrent chemoradiotherapy	From baseline to day 7.	Compare the proportion of patients whom complete chemotherapy between the two groups.
Weight change	From baseline to day 7.	Compare the reduction in mean weight during radiotherapy between the two groups.
Food intake (liquid food, semi liquid food)	From baseline to day 7.	Compare intake ability of food (liquid food, semi liquid food) between the two groups.; Effective:dietary has improved (for example, changing from liquid food to semi liquid food, from semi liquid food to soft food, or from soft food to regular diet) Ineffective: the patients can not eat, or need tube feedings, or parenteral nutrition.

Trial Locations

Locations (12)

Second hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Henan Cancer Hospital; 🇨🇳 Zhenzhou, Henan, China

Yue Bei People's Hospital; 🇨🇳 Shaoguan, Guangdong, China

Affiliated Hospital of Jiangsu University; 🇨🇳 Nanjing, Jiangsu, China

Haici Medical Group; 🇨🇳 Qingdao, Shandong, China

Nanyang Central Hospital; 🇨🇳 Nanyang, Henan, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Henan Anyang Tumor Hospital; 🇨🇳 Anyang, Henan, China

Zhenzhou Central Hospital; 🇨🇳 Zhenzhou, Henan, China

Weihai Municipal Hospital; 🇨🇳 Weihai, Shandong, China

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Liaoning Cancer Hospital & Institue; 🇨🇳 Shenyang, Liaoning, China